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NCT Number: NCT07004777

Effect of Consuming n-3 Polyunsaturated Fatty Acids Rich Foods on Triglyceride Concentration and Lipoprotein Composition

Hypertriglyceridemia is one of the most prevalent lipid profile disorders and is linked to a large proportion of mortality in Mexico and around the world. Various international treatment guidelines for hypertriglyceridemia have suggested the consumption of foods rich in n-3 polyunsaturated fatty acids or their intake through supplementation as a complement to lifestyle changes. However, adherence to the consumption of foods and supplements containing these fatty acids is often limited due to lack of acceptance or unaffordability. For this reason the objective of the study is to evaluate the effect of including Mexican foods rich in n-3 polyunsaturated fatty acids (chia seeds and pumpkin seeds) within a diet based on NCEP-ATPIII recommendations on triacylglycerol concentration and fatty acid profile in people with hypertriglyceridemia.

The study will consist of a 4-week period in which one group of participants will be randomized into two treatment groups: 1)isocaloric diet based on the NCEP-ATPIII dietary recommendations; 2) isocaloric diet based on the NCEP-ATPIII dietary recommendations plus chia and pumpkin seeds. The effect of the dietary intervention will be assessed by concentration of triglycerides, fatty acids profile and lipoprotein analysis.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

Location status: Recruiting

Location contact

Armando Tovar, PhD

CONTACT

[email protected]

+525554870900 ext. 2801

Martha Guevara, MD, PhD

PRINCIPAL_INVESTIGATOR

Martha Guevara-Cruz, MD, PhD

CONTACT

[email protected]

+525554870900 ext. 2802

About this study

The study will consist of a 4-week period in which one group of participants will be given a diet based on the NCEP-ATPIII dietary recommendations, and another group will receive the same diet plus chia and pumpkin seeds. If participants maintain triglyceride levels >200 mg/dL, they will be given fish oil supplementation for an additional 4 weeks to reinforce the dietary treatment (NCEP-ATPIII dietary recommendations).

Participants will be screened to ensure they meet the inclusion criteria. Those who agree to participate will be required to sign an informed consent form. At both the beginning and the end of the 4-week period, participants will undergo a medical history assessment, anthropometric measurements (weight, height, and waist circumference), body composition analysis (including body fat percentage, skeletal muscle mass percentage, and lean body mass percentage), blood pressure measurement, evaluation of hepatic steatosis using transient elastography and; pulse wave velocity.

In addition, blood samples will be collected to determine serum glucose levels; lipid profile parameters (total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides); inflammatory, oxidative, and endothelial markers; and genetic polymorphisms related to lipid metabolism, particularly n-3 polyunsaturated fatty acids (PUFAs) (FADS1 and FADS2). Monocytes will also be isolated to assess mitochondrial function.

Furthermore, serum concentrations of phosphatidylcholine species (16:0_20:5 and 16:0_22:6), lipoprotein composition, and fatty acid profiles will be analyzed using gas chromatography.

Participants with hypertriglyceridemia will be randomly assigned to two groups. Both groups will be prescribed an isocaloric diet; however, only one group will additionally include a food rich in n-3 PUFAs:

  • An isocaloric diet based on NCEP-ATPIII dietary recommendations.
  • An isocaloric diet based on NCEP-ATPIII dietary recommendations including chia and pumpkin seeds.

Resting energy expenditure wil be measured by indirect calorimetry to determine energy requirement of each participant. Distribution of micronutrients of the dietary intervention will be as follow: 50% carbohydrates, 20% protein, and 30% lipids .

This dietary intervention will last 4 weeks. To promote adherence, participants will be given foods rich in n-3 PUFA.

Participants with triglyceride levels >200 mg/dL after the 4-week dietary intervention period will receive fish oil supplementation for an additional 4 weeks. At the end of this period, anthropometric measurements (weight, height, and waist circumference), body composition analysis (including body fat percentage, skeletal muscle mass percentage, and lean body mass percentage), blood pressure measurement, and hepatic steatosis assessment using transient elastography will be repeated. Blood samples will be collected again to determine serum glucose levels and lipid profile parameters (total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides).

During the whole study dietary intake and the adherence to dietary treatment will be monitored using 24-hour dietary recalls, which will be conducted during all visits, as well as through phone calls 2 times per week and text messages.

In addition to the above, the concentration of fatty acids in serum will be evaluated and compared over a 24-hour period following the intake of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) supplements (fish oil) vs. that of foods rich in n-3 polyunsaturated fatty acids (salmon fish, Sierra fish and chia seeds and pumpkin seeds).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signing of the informed consent form
  • Both sexes.
  • Adults over 18 years of age.
  • BMI >18.5 kg/m2.
  • Triglycerides between 200 and 500 mg/dL.
  • Total cholesterol less than 240 mg/dL

Exclusion criteria

  • Any type of diabetes.
  • kidney disease diagnosed by a physician.
  • Acquired diseases that secondarily cause obesity and diabetes.
  • Patients who have suffered a cardiovascular event.
  • Weight loss >3 kg in the last 3 months.
  • Catabolic diseases such as cancer and acquired immunodeficiency syndrome.
  • Pregnancy.
  • Treatment with any medication:
  • Treatment with antihypertensive drugs (tricyclic, loop, or potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, alpha-blockers, calcium channel blockers, beta-blockers).
  • Treatment with hypoglycemic agents (sulfonylureas, biguanides, incretins) or - insulin and antidiabetics.
  • Treatment with statins, fibrates, or other drugs to control dyslipidemia.
  • Use of steroid medications, chemotherapy, immunosuppressants, or radiation therapy.
  • Anorectic agents or those that accelerate weight loss.
  • Treatment with any medication that influences inflammation (corticosteroids, nonsteroidal anti-inflammatory drugs, colchicine, interleukin-1 inhibitors) or triglyceride metabolism (metformin, glitazones, SGLT2 inhibitors, fibrates, statins, cholesterol ester transporter protein (CETP) inhibitors, pancreatic lipase inhibitors).
  • Anticoagulants and antiplatelets (warfarin, aspirin, clopidogrel).
  • People with a smoking cessation index (SCI) greater than 21.
  • People with a tobacco Index greater than 21.
  • Consumption of large amounts of alcohol (14 drinks for women or 21 drinks for men in a typical week).
  • Consumption of any recreational psychoactive substance.
  • Allergy or intolerance to any food listed in the proposed pantry.
  • Unwillingness to consume any of the foods listed in the proposed pantry.
  • Previous n-3 PUFA supplementation.

Treatment and study plan

Isocaloric diet including chia and pumpkin seeds

Dietary Supplement

Diet based on participant-specific energy expenditure. With the following macronutrient distribution: 50% carbohydrates, protein 20% and 30% fats.

This dietary intervention consists of a four-week follow-up period and incorporates the intake of pumpkin and chia seeds.

isocaloric diet

Other

Diet based on participant-specific energy expenditure. With the following macronutrient distribution: 50% carbohydrates, protein 20% and 30% fats.

This dietary intervention consists of a four-week follow-up period.

Primary outcomes

  1. Serum triglycerides concentration in mg/dL

    Time frame: From baseline to week 4 of the intervention

    Change in serum triglycerides between different nutrition interventions.

  2. Serum fatty acid profile analysis by gas chromatography in microgram

    Time frame: From baseline to week 4 of the intervention

    Change in serum fatty acid between different nutrition interventions.

Secondary outcomes

  1. Serum total cholesterol concentration in mg/dL

    Time frame: From baseline to week 4 of the intervention

    Change in serum total cholesterol between different nutrition interventions.

  2. Serum LDL cholesterol concentration in mg/dL

    Time frame: From baseline to week 4 of the intervention

    Change in serum LDL cholesterol between different nutrition interventions.

  3. Serum HDL cholesterol concentration in mg/dL

    Time frame: From baseline to week 4 of the intervention

    Change in serum HDL cholesterol between different nutrition interventions.

  4. Serum lipids concentration in relative peak area

    Time frame: From baseline to week 4 of the intervention

    Change in serum lipids between different nutrition interventions.

  5. Serum C-reactive protein concentration in mg/dL

    Time frame: From baseline to week 4 of the intervention

    Change in serum C-reactive protein between different nutrition interventions.

  6. Plasma malondialdehyde concentration in nmol/mL

    Time frame: From baseline to week 4 of the intervention

    Change in plasma malondialdehyde between different nutrition interventions.

  7. Serum Intercellular Adhesion Molecule-1 (ICAM-1) concentration in pg/mL

    Time frame: From baseline to week 4 of the intervention

    Change in serum ICAM-1 between different nutrition interventions.

  8. Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) concentration in pg/mL

    Time frame: From baseline to week 4 of the intervention

    Change in serum VCAM-1 between different nutrition interventions.

  9. Serum plasminogen concentration in mg/dL

    Time frame: From baseline to week 4 of the intervention

    Change in serum plasminogen between different nutrition interventions.

  10. Serum glucose concentration in mg/dL

    Time frame: From baseline to week 4 of the intervention

    Change in serum glucose between different nutrition interventions.

  11. Serum aspartate aminotransferase concentration in IU/mL

    Time frame: From baseline to week 4 of the intervention

    Change in serum aspartate aminotransferase between different nutrition interventions.

  12. Serum alanine aminotransferase concentration in IU/mL

    Time frame: From baseline to week 4 of the intervention

    Change in serum alanine aminotransferase between different nutrition interventions.

  13. Serum insulin concentration in micro - IU / ml

    Time frame: From baseline to week 4 of the intervention

    Change in serum insulin between different nutrition interventions.

  14. Oxygen consumption rate in pmol / number of cells

    Time frame: From baseline to week 4 of the intervention

    Change in oxygen consumption rate between different nutrition interventions.

  15. Body weight in kilograms

    Time frame: From baseline to week 4 of the intervention

    Change in body weight between different nutrition interventions.

  16. Waist circumference in centimeters

    Time frame: From baseline to 4 week of the intervention

    Change in waist circumference between different nutrition interventions.

  17. Fat mass percentage

    Time frame: From baseline to 4 week of the intervention

    Change in fat mass percentage between different nutrition interventions.

  18. Skeletal muscle mass percentage

    Time frame: From baseline to 4 week of the intervention

    Change in skeletal muscle mass percentage between different nutrition interventions.

  19. Lean mass percentage

    Time frame: From baseline to 4 week of the intervention

    Change in lean mass percentage between different nutrition interventions.

  20. Medium very low density lipoprotein (VLDL) particle number in nmol/L

    Time frame: From baseline to 4 week of the intervention

    Change in plasma medium VLDL particle number between different nutrition interventions.

  21. Large very low density lipoprotein (VLDL) particle number in nmol/L

    Time frame: From baseline to 4 week of the intervention

    Change in plasma large VLDL particle number between different nutrition interventions.

  22. Small very low density lipoprotein (VLDL) particle number in nmol/L

    Time frame: From baseline to 4 week of the intervention

    Change in plasma small VLDL particle number between different nutrition interventions.

  23. Large LDL particle number in nmol/L

    Time frame: From baseline to 4 week of the intervention

    Change in plasma large LDL particle number between different nutrition interventions.

  24. Medium LDL particle number in nmol/L

    Time frame: From baseline to 4 week of the intervention

    Change in plasma medium LDL particle number between different nutrition interventions.

  25. Small LDL particle number in nmol/L

    Time frame: From baseline to 4 week of the intervention

    Change in plasma small LDL particle number between different nutrition interventions.

  26. Large HDL particle number in nmol/L

    Time frame: From baseline to 4 week of the intervention

    Change in plasma large HDL particle number between different nutrition interventions.

  27. Small HDL particle number in nmol/L

    Time frame: From baseline to 4 week of the intervention

    Change in plasma small HDL particle number between different nutrition interventions.

  28. Medium HDL particle number in nmol/L

    Time frame: From baseline to 4 week of the intervention

    Change in plasma medium HDL particle number between different nutrition interventions.

  29. Pulse wave velocity in m/s

    Time frame: From baseline to 4 week of the intervention

    Change in pulse wave velocity between different nutrition interventions

  30. Controlled attenuation parameter in decibels per meter

    Time frame: From baseline to 4 week of the intervention

    Allows to evaluate the degree of steatosis by elastography.

Study contacts

Contact information is provided by the study sponsor or research team.

Armando Tovar, PhD

CONTACT

[email protected]

+52 55 5487 0900 ext. 2802

Martha Guevara, MD, PhD

CONTACT

[email protected]

+52 55 5487 0900 ext. 2802

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Official study title

Effect of Consuming n-3 Polyunsaturated Fatty Acids Rich Foods on Triglyceride Concentration and Lipoprotein Composition in Individuals With Hypertriglyceridemia. Controlled Clinical Trial.

Acronym: SALVIMEX

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 4, 2025
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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